Sainath Kumar

About Sainath Kumar

Statistical programming professional with 12+ years of experience in analysis, design, development, testing, and implementation of Clinical Trial projects within the Pharmaceutical, CRO, and Biotech industries. I possess a deep understanding of life sciences and the drug development process, spanning from protocol design to FDA submissions across all clinical trial phases (I-IV). My expertise includes therapeutic areas such as Infectious Diseases, Virology, HIV, Respiratory, Vaccines, Immunology, and Gastroenterology.I have extensive experience in SAP/OPS preparation, along with a thorough knowledge of clinical trial phases, clinical protocols, CRFs, annotated CRFs, ICH and GCP guidelines, and 21 CFR regulations. I am also well-versed in electronic submissions to the FDA.My technical skills include excellent SAS programming capabilities, particularly in implementing CDISC for special purpose domains, events, findings, interventions, and trial domains. I am adept at implementing ADaM (Analysis Data Model) and generating analysis datasets specific to clinical studies. I have a proven track record in producing and validating Tables, Listings, and Graphs (TLFs) using Base SAS, SAS/Graph, SAS/Macros, and SAS/ODS. Additionally, I have experience with ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) for FDA submissions according to the Statistical Analysis Plan (SAP).In the realm of clinical programming, I excel in activities such as eCRF design using EDC systems like Medidata Rave and report creation. I am proficient in developing and testing clinical study EDC databases (Medidata Rave and Inform), including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, and custom functions.I am skilled in using SQL, PL/SQL, SAS Programming, R, and Python for data manipulation, analysis, and visualization.Key Skills: SQL, PL/SQL, SAS Programming, R, PythonCertifications: Oracle Certified Associate in SQL and PL/SQL

Experience

1. Principal Statistical Programmer

   Oryxion

   Sep 2024 — Present

   Developing SAS macros, templates and utilities for data cleaning and reporting. Utilize ADaM guidelines to build datasets.• Overseeing outsourced tasks to third party vendors and ensure their performance meets the agreed timelines, quality and budget requirements established for the project or study.• Define, develop, and embed data standards within a function, or therapeutic area in accordance with industry standards.• Review CRF annotations and data specifications.• Responsible for programming and QC across a study/asset including submission activities adhering to relevant SOPs / policies.• Performs review on define.xml and creates reviewers guide for SDTM and ADaM datasets using SAS.• Participated in the design of other study delivery components (e.g. case report forms, study databases).• Communicate with an internal team to create deliverables for pharmaceutical and biotechnology clients.• Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician.• Creation of R and SAS programs to generate tables, listings, and figures and analysis datasets per study requirement.• Resourcing and planning of the study deliverable per agreed timelines.• Worked on ADRG drafting and also eCRT packages creation and Archival activities.• Performed Oversight Qc for outsourced studies by leading the study team.• Worked with Biostatistics and Data Management member on various clinical projects.• Develop SAS coding and table templates for preparing, processing and analyzing clinical data.• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.

Education

• Visvesvaraya Technological University

  Bachelor of Engineering - BE, Information Technology

• M.E.S College of Arts, Science and Commerce, Malleshwaram, Bangalore-3

  11th and 12th , SCIENCE